Tarfazolin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TARFAZOLIN, 1 g, powder for solution for injection and infusion
Cefazolinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• This medicine may harm another person, even if their symptoms are identical.
• If any adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor immediately.

Table of contents

1. What Tarfazolin is and what it is used for
2. Important information before using Tarfazolin
3. How to use Tarfazolin
4. Possible side effects
5. How to store Tarfazolin
6. Contents of the pack and other information

1. WHAT TARFAZOLIN IS AND WHAT IT IS USED FOR

Tarfazolin contains the active substance cefazolinum. Cefazolin is an antibiotic belonging to the group of so-called cephalosporins—antibiotics similar to penicillin.

Indications
Tarfazolin is indicated for the treatment of the following infections caused by microorganisms sensitive to cefazolin:

• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Biliary tract infections
• Septicaemia
• Endocarditis
• Prophylaxis of perioperative infections in patients at increased risk of infection, e.g. cholecystectomy in high-risk patients (especially over 70 years of age, patients with acute cholecystitis, obstructive jaundice, or gallstones), or following appendectomy, uterine resection, or caesarean section; or in patients in whom infection at the surgical site would be particularly dangerous (e.g. in cardiac surgery, orthopedic surgery, especially endoprosthesis implantation).

2. IMPORTANT INFORMATION BEFORE USING TARFAZOLIN

When not to use Tarfazolin
Do not use Tarfazolin if the patient is allergic (hypersensitive) to cefazolin or to other cephalosporin antibiotics.

Warnings and precautions

• Patients who are allergic to penicillins may also be allergic to cephalosporins.
• If the patient has previously experienced an allergic reaction to penicillins or other beta-lactam antibiotics, inform the doctor before starting treatment. Special caution will be necessary.
• If an allergic reaction occurs, characterized by sudden wheezing, difficulty breathing, eyelid, facial or lip swelling, rash, or itching, the patient must stop taking the medicine and seek immediate medical attention.

Also inform the doctor if:

• The patient develops a rash during treatment—the doctor may decide to change the medicine;
• The patient has factors that may cause vitamin K deficiency or coagulation disorders for other reasons (such as parenteral nutrition, impaired liver or kidney function, haemophilia, thrombocytopenia);
• The patient has impaired renal function—the doctor will adjust the dosage according to the degree of renal impairment;
• The patient develops severe and persistent diarrhoea during or after treatment with Tarfazolin. The patient should not use antidiarrhoeal agents that inhibit intestinal peristalsis;
• The patient develops a new infection (e.g. fungal infection) during treatment with Tarfazolin; the doctor may then decide to discontinue the medicine.

Other medicines and Tarfazolin
Inform the doctor about all medicines currently used, recently used, or planned for use.
In particular, inform the doctor if the patient is taking:

• Probenecid (a medicine used in gout and other conditions);
• Aminoglycoside antibiotics (e.g. streptomycin, tobramycin, gentamicin).

Effect on laboratory test results
Tarfazolin may interfere with certain laboratory tests, such as tests for glucose (sugar) in urine and certain blood tests (Coombs’ test).

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.
Avoid using Tarfazolin during pregnancy unless the doctor considers its use necessary.
The medicine is excreted in small amounts in breast milk; therefore, it should be used cautiously in breastfeeding women.

Driving and operating machinery
There is no data available regarding the effect of the medicine on the ability to drive or operate machinery.

3. HOW TO USE TARFAZOLIN

The patient does not use this medicine independently.
The medicine will be administered by a qualified healthcare professional, i.e. a doctor or nurse.
Tarfazolin may be given by intramuscular or intravenous injection or by intravenous infusion.

Adults
Tarfazolin is usually administered in doses of 500 mg to 1500 mg every 6, 8 or 12 hours, depending on the severity of infection.
The maximum daily dose of cefazolin is 12 g.

Children
The usual dose is 25 mg to 50 mg/kg body weight per day, given in divided doses every 6 or 8 hours. In severe infections, the dose may be increased to 100 mg/kg body weight per day.

If during treatment the patient feels that the effect of the medicine is too strong or too weak,
the patient should consult a doctor.

Duration of treatment
The duration of treatment will be determined by the doctor depending on the severity and type of infection. It is important to follow the doctor's instructions.

Administration and preparation of solutions
Detailed information is provided at the end of this leaflet in the section intended for medical personnel – "Information exclusively for healthcare professionals".

Use of a higher than recommended dose of Tarfazolin
Administration of a dose higher than recommended is unlikely. The patient should contact their doctor, pharmacist or nurse as soon as possible if they believe they have received an overdose. Overdose may intensify adverse effects, including central nervous system irritation and seizures.

If in doubt about how to administer the medicine, consult a doctor, pharmacist or nurse.

Missed dose of Tarfazolin
If a dose is missed at the scheduled time, the medicine should be administered as soon as possible, provided that there is sufficient time before the next dose is due, or continue with the regular dosing schedule. Do not administer a double dose to make up for a missed dose.

Stopping treatment with Tarfazolin
It is important to use the medicine exactly as prescribed for the full duration of treatment. Do not stop treatment just because the patient feels better. If treatment is stopped too early, the infection may return.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Tarfazolin can cause the following adverse reactions, although they do not occur in everyone.

Serious adverse reactions

• Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty in
  swallowing (severe allergic reaction)
• Widespread skin rash, with possible blisters and peeling of the skin, particularly around the mouth, nose, eyes and genital organs
• Severe diarrhoea, persisting for a prolonged period or containing blood, accompanied by abdominal pain and fever. This may be a sign of a serious intestinal inflammation (called pseudomembranous colitis), which may occur after antibiotic treatment.

If any of these symptoms occur, contact a doctor immediately. Treatment with Tarfazolin must be discontinued.

Other adverse reactions that should be reported to a doctor if they occur

Not very common (in 1 to 10 out of 100 patients)
Redness, pain at the site of intramuscular injection.

Rare (in 1 to 10 out of 1,000 patients)
Oral fungal infection (thrush)
Diarrhoea, nausea, vomiting, loss of appetite, abdominal pain
Thrombophlebitis after intravenous administration

Very rare (less than 1 in 10,000 patients)
Yellowing of the skin, dark urine and fatigue – may be signs of liver problems

Frequency not known (cannot be estimated from available data)
Genital fungal infection
Increase or decrease in the number of certain blood cells
Rashes
Transient increase in activity of certain liver enzymes

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor, nurse or pharmacist.

5. HOW TO STORE TARFAZOLIN

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Tarfazolin contains
The active substance is cefazolin (in the form of cefazolin sodium).
Each vial contains 1 g of cefazolin.
The medicine does not contain any other ingredients.

What Tarfazolin looks like and contents of the pack
Crystalline, white or almost white powder.
Packaging: One vial in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Telephone number: 22 811-18-14

For further information, please contact the representative of the Marketing Authorisation Holder.

The following information is intended exclusively for medical or healthcare personnel

For additional information, see the Summary of Product Characteristics.
Instructions for preparation and administration of the medicinal product
Any unused product or waste material must be disposed of in accordance with
local regulations.
Preparation of solutions
Intramuscular injections
Dissolve the contents of the 1 g vial in approximately 3 ml of water for injections. Gently
shake before use.
Inject deeply into large muscle groups.
Solutions prepared for intramuscular injection must be used immediately after
preparation.
Intravenous injections
Dissolve the contents of the 1 g vial in at least 10 ml of water for injections. Gently
shake before use.
Inject slowly over approximately 3 to 5 minutes.
Intravenous infusions
Dilute the solution prepared as for intravenous injection in 50 to 100 ml of 5% or 10% glucose solution, Ringer's solution, or 0.9% sodium chloride solution, and administer into large veins.
Solutions prepared for intravenous injection or infusion remain stable for 24
hours at 2 °C to 8 °C (refrigerator).
A change in solution colour to yellow (straw-coloured) does not affect the activity or
properties of the preparation.
Cefazolin must not be mixed in the same syringe with other medicinal products.